Glossary
D-value
The time or absorbed dose required, under defined sterilising conditions, to reduce the number of surviving organisms to 10% of the original number.
Source · EudraLex Volume 4, Annex 1 (2022), §11 Glossary: D-value
Details
The D-value puts a number on the heat or radiation resistance of the biological indicator and the target organisms, and is the basis on which the lethality of a sterilisation cycle is designed. Inspections cite weak correlation between the D-value of the strain and lot in use, the population and purity checks, and the process conditions. Check the BI certificate and incoming testing, the cycle development calculations, the heat distribution and penetration raw data, and change records.
Related sections
Related terms
Source
EudraLex Volume 4, Annex 1 (2022), §11 Glossary: D-valueGRM Regulatory Glossary
243 GMP terms in one place
Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.
Browse the whole glossary